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Device
prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
Regulation Description
Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
Regulation Medical Specialty
Orthopedic
Review Panel
Orthopedic
Product Code
MBH
Premarket Review
Office of Orthopedic Devices
(OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type
510(k)
Regulation Number
888.3565
Device Class
2
Total Product Life Cycle (TPLC)
TPLC Product Code Report
GMP Exempt?
No
Summary Malfunction
Reporting
Eligible
Implanted Device?
Yes
Life-Sustain/Support Device?
No
Recognized Consensus Standards
8-195 ASTM F2024-10 (Reapproved 2016)
Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
8-380 ASTM F1160-14 (Reapproved 2017)e1
Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
8-427 ASTM F1185-03 (Reapproved 2014)
Standard Specification for Composition of Hydroxylapatite for Surgical Implants
8-493 ISO 13779-2 Third edition 2018-12
Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
8-516 ISO 13779-4 Second edition 2018-12
Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
8-577 ISO 13179-1 Second Edition 2021-09
Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders
8-579 ISO 13779-3 Second Edition 2018-12
Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)]
8-585 ASTM F1377-21
Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
8-593 ISO 13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15
Implants for surgery - Hydroxyapatite - Part 6: Powders
11-197 ASTM F983-86 (Reapproved 2018)
Standard Practice for Permanent Marking of Orthopaedic Implant Components
11-199 ASTM F565-04 (Reapproved 2018)
Standard Practice for Care and Handling of Orthopedic Implants and Instruments
11-232 ISO 7207-1 Third edition 2007-02-01
Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions
11-281 ASTM F1672-14 (Reapproved 2019)
Standard Specification for Resurfacing Patellar Prosthesis
11-308 ASTM F3161-16
Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
11-311 ISO 14243-2 Third edition 2016-09-01
Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
11-335 ASTM F3141-17a
Standard Guide for Total Knee Replacement Loading Profiles
11-342 ASTM F732-17
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
11-361 ISO 14243-5 First edition 2019-05
Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint
11-364 ISO 14243-1 Second edition 2009-11-15
Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
11-365 ASTM F1800-19 e1
Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
11-367 ISO 14243-3 Second edition 2014-11-01
Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
11-368 ASTM F3334-19
Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
11-370 ISO 14879-1 Second edition 2020-07
Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
11-373 ASTM F1223-20
Standard Test Method for Determination of Total Knee Replacement Constraint
11-374 ISO 7207-2 Second edition 2011-07-01
Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016) and AMENDMENT 2 (2020)]
11-377 ASTM F2083-21
Standard Specification for Knee Replacement Prosthesis
11-395 ASTM F1814-22
Standard Guide for Evaluating Modular Hip and Knee Joint Components
11-397 ASTM F3210-22e1
Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
11-400 ISO 21536 Third edition 2023-07
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
11-406 ASTM F3141-23
Standard Guide for Total Knee Replacement Loading Profiles
11-408 ASTM F2777-23
Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
Guidance Document
Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA
Third Party Review
Not Third Party Eligible
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